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Trial ID IM047-001  |   NCT05076175

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

Summary

  • Phase 2/Phase 3
  • Male and Female Gender icon
  • 2-17
    Age Range
  • 32
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit
    1. Evidence of UC extending beyond the rectum, as determined by baseline endoscopy
      1. Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy

        Exclusion Criteria

        Exclusion Criteria Icon
        • Diagnosis of Crohn's disease or indeterminate colitis
          1. Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stool
            1. Apheresis within 2 weeks of randomization
              1. History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitis
                1. Other protocol-defined inclusion/exclusion criteria apply
                  Additional Information *

                  Treatment Options

                  Study Arms

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Ozanimod High Dose

                  ASSIGNED INTERVENTION
                  • Drug: Ozanimod

                  Study Arms

                  Experimental: Ozanimod Low Dose

                  ASSIGNED INTERVENTION
                  • Drug: Ozanimod
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